NCT00823979终止2 期
A Phase 2b Multicenter, Randomized, Comparative Trial Of Uk-453,061 Versus Etravirine In Combination With Darunavir/Ritonavir And A Nucleotide/Nucleoside Reverse Transcriptase Inhibitor For The Treatment Of Antiretroviral Experienced Hiv-1 Infected Subjects With Evidence Of Nnrti Resistant Hiv-1
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 105
- 试验地点
- 63
- 主要终点
- Percentage of Participants With Human Immunodeficiency Virus Type 1 Ribonucleic Acid (HIV-1 RNA) Levels Less Than (<) 50 Copies/Milliliter (mL) at Week 24
研究概览
简要总结
This is a 96 week study to determine if UK- 453,061 in combination with Darunavir /ritonavir and a Nucleos(t)ide Reverse Transcriptase inhibitor is as efficacious, safe and tolerable as etravirine in combination with Darunavir /ritonavir and a Nucleos(t)ide Reverse Transcriptase inhibitor in HIV-1 infected patients who have been previously treated with antiretroviral drugs and have NNRTI resistance mutations.
详细描述
The trial was terminated on 12 April, 2012 due to lack of efficacy at the Week 24 analysis. The decision to terminate the trial was not based on any safety concerns.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female at least 18 years of age available for a follow-up period of at least 96 weeks.
- •HIV 1 RNA viral load of greater then 500 copies/mL.
- •Negative urine pregnancy test.
排除标准
- •Suspected or documented active, untreated HIV-1 related opportunistic infection or other condition requiring acute therapy at the time of randomization.
- •Subjects with acute Hepatitis B and/or C within 30 days of randomization.
- •Previous use of Darunavir or etravirine
研究组 & 干预措施
UK- 453,061 Dose One
Experimental
干预措施: UK-453,061 Dose 1 (Drug)
UK- 453,061 Dose Two
Experimental
干预措施: UK-453,061 Dose 2 (Drug)
Comparator
Active Comparator
干预措施: Etravirine (Drug)
结局指标
主要结局
Percentage of Participants With Human Immunodeficiency Virus Type 1 Ribonucleic Acid (HIV-1 RNA) Levels Less Than (<) 50 Copies/Milliliter (mL) at Week 24
时间窗: Week 24
Plasma HIV-1 RNA level was determined by the Roche Amplicor HIV-1 Monitor standard assay (version 1.5).
次要结局
- Percentage of Participants With HIV-1 RNA Levels <50 Copies/mL at Week 48 and 96(Weeks 48, 96)
- Percentage of Participants With HIV-1 RNA Levels <400 Copies/mL at Week 24, 48 and 96(Week 24, 48, 96)
- Change From Baseline in log10 Transformed HIV-1 RNA Levels at Week 24, 48 and 96(Baseline, Week 24, 48, 96)
- Percentage of Participants With Response as Determined by the Time to Loss of Virologic Response (TLOVR50) Algorithm at Week 24, 48 and 96(Week 24, 48, 96)
- Change From Baseline in Cluster of Differentiation 4 (CD4+) Absolute Lymphocyte Counts at Week 24, 48 and 96(Baseline, Week 24, 48, 96)
- Change From Baseline in Cluster of Differentiation 4 (CD4+) Percentage Lymphocyte Counts at Week 24, 48, 96(Baseline, Week 24, 48, 96)
- Number of Participants With Non-nucleoside Reverse Transcriptase Inhibitors (NNRTI) Resistance-Associated Mutations (RAMs) and/or Phenotypic Susceptibility at Time of Treatment Failure Through Week 48(Baseline through Week 48)
- Number of Participants With Laboratory Test Abnormalities(Baseline up to Week 48 or early termination)
- Population Pharmacokinetics (PK) of Lersivirine(Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48)
- Lersivirine Success Percentage With Reference to Median Minimum Observed Plasma Concentration (Cmin)(Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48)
- Time-Averaged Difference (TAD) in log10 Transformed HIV-1 RNA Levels at Week 24, 48 and 96(Week 24, 48, 96)
研究者
研究点 (63)
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